NDC 36800-101

Nitetime Sinus Relief

Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride

Nitetime Sinus Relief is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Top Care (topco Associates Llc). The primary component is Acetaminophen; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 36800-101_8661dd9d-570c-4be0-b3bd-6e7f64d394a7
• NDC: 36800-101
• Product Type: Human Otc Drug
• Proprietary Name: Nitetime Sinus Relief
• Generic Name: Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-01
• Marketing End Date: 2020-12-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: TOP CARE (Topco Associates LLC)
• Substance Name: ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N

Packaging

NDC 36800-101-16

2 BLISTER PACK in 1 CARTON (36800-101-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2012-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-101-24 [36800010124]

Nitetime Sinus Relief CAPSULE, LIQUID FILLED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-09-01
• Marketing End Date: 2020-12-31

NDC 36800-101-16 [36800010116]

Nitetime Sinus Relief CAPSULE, LIQUID FILLED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-09-01
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: dc65aeb9-b109-4432-8bde-11762e795fda
• Manufacturer:
  • TOP CARE (Topco Associates LLC)
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052647
• UPC Code:
  • 4128709384187

NDC Crossover Matching brand name "Nitetime Sinus Relief" or generic name "Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
36800-101	Nitetime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride
51013-156	NiteTime Sinus Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate
51013-114	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
63868-464	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
69842-074	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
55315-102	Night Time Sinus	Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride
53345-031	NightTime Sinus	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
53345-013	NightTime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride